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August 2026
Letter: FDA Approval of the HepQuant SHUNT Liver Diagnostic Test and Clarification of the SHUNT-V Analysis Cohort
| Alimentary Pharmacology & Therapeutics
DOI: 10.1111/apt.70925 | PubMed ID: 42576259
A recent Letter to the Editor provides additional context regarding the difference between the SHUNT-V study population reported in Alimentary Pharmacology & Therapeutics and the clinical validation dataset included in the FDA-approved labeling for the HepQuant SHUNT® Liver Diagnostic Test. read more →
HepQuant SHUNT
July 2026
Simultaneous quantification of native human and transgenic porcine liver function in a decedent model of extracorporeal cross-circulation
| American Journal of Transplantation
DOI: 10.1016/j.ajt.2026.02.016 | PubMed ID: 41724435
Porcine livers have the potential to support liver function via extracorporeal liver cross-circulation (ELC) until recovery or transplantation. To assess the functional integrity of both native human and porcine livers during ELC, we used the clearance of intravenously administered 13C-cholate to probe effective hepatic perfusion in 4 decedents maintained on ELC for 72 to 102 hours. Genetically modified porcine livers (EGEN-5784) were perfused using the OrganOx metra-ELC device. Hepatic filtration rate was calculated for the native human liver and the EGEN-5784 liver in ELC. During ELC, total hepatic filtration rate increased substantially compared with pre-ELC values, exceeded the upper limit of the normal range, and remained stable throughout the ELC period. Simultaneous measurement of cholate clearance in human and porcine livers during ELC provides real-time assessment of each organ’s functional contribution and may inform decisions regarding optimal ELC duration, timing of disconnection, and necessity of liver transplantation. read more →
May 2026
Evidence Supporting Utility of the Oral Cholate Challenge Test of Liver Function and Physiology to Aid Clinical Management: A Review of Analytical and Clinical Validation Studies
| Gastro Hep Advances
DOI: 10.1016/j.gastha.2026.100993 | PubMed ID: 42293780
Current liver assessments rely on liver stiffness measurements as surrogates for liver fibrosis or static laboratory values that reflect advanced disease or liver injury rather than overall hepatic function and physiology. The oral cholate challenge test (OCCT), HepQuant DuO® offers a noninvasive, blood-based, measure of liver function by assessing cholate clearance, which is hepatocyte specific and liver blood flow dependent. Clinical studies show its key metrics - Disease Severity Index (DSI), SHUNT%, and Hepatic Reserve - correlate with portal hypertension, varices, decompensation risk, and treatment response. These measures may outperform conventional liver tests and complement imaging or histology. The OCCT also shows promise as a monitoring tool in chronic liver disease drug trials, potentially improving both patient management and therapeutic development. read more →
HepQuant DuO
March 2026
Beyond Liver Function Tests, Liver Stiffness, and Portal Pressure: Portal-Systemic Shunting as a New Endpoint for Clinical Trials of Cirrhosis and Portal Hypertension.
| Gastro Hep Advances
DOI: 10.1016/j.gastha.2026.100935 | PubMed ID: 42089005
This commentary proposes the oral cholate challenge test (OCCT), specifically its Disease Severity Index (DSI) and measurement of portal-systemic shunting (SHUNT%), as a practical, clinically meaningful, and noninvasive complement or alternative to traditional tools like liver stiffness measurement and HVPG for assessing portal hypertension risk, esophageal varices, and prognosis in MASH-related cirrhosis. Since the OCCT directly reflects liver function and portal-systemic shunting, it could improve patient stratification and serve as a stronger endpoint for clinical management and drug development in this population. read more →
HepQuant DuO
February 2026
Extracorporeal liver cross-circulation using transgenic xenogeneic pig livers with brain-dead human decedents
| Nature Medicine
DOI: 10.1038/s41591-025-04196-3 | PubMed ID: 41663593
Extracorporeal liver cross-circulation (ELC) using genetically modified pig livers may address an unmet need for temporary liver support in patients with acute or acute-on-chronic liver failure. read more →
January 2026
HMG-CoA Reductase Inhibitors (Statins) May Preserve Hepatic Function and Reduce Portal-Systemic Shunting in Compensated Advanced Chronic Liver Disease: Results from the SHUNT-V Study
| Clinical and Translational Gastroenterology
DOI: 10.14309/ctg.0000000000000980 | PubMed ID: 41586527
Background and Aims: Factors associated with decline of hepatic function and increase in portal-systemic shunting, which herald clinical outcome in persons with compensated cirrhosis, are poorly characterized. We used cholate challenge to evaluate the associations of liver disease etiology, concomitant diabetes, and maintenance drug therapy, with the degree of hepatic dysfunction and portal-systemic shunting.
Conclusions: Concomitant use of statins alone or in combination with metformin was independently associated with preserved hepatic function (DSI) and reduced portal-systemic shunting (SHUNT%). read more →
HepQuant DuO, HepQuant SHUNT
January 2026
When should I repeat the endoscopy in my patient with compensated cirrhosis, whom I just scoped and who had no or small varices?
| Translational Gastroenterology and Hepatology
DOI: 10.21037/tgh-25-133 | PubMed ID: 41675321
Current endoscopic surveillance intervals for patients with compensated advanced chronic liver disease (cACLD) are based primarily on the presence or size of esophageal varices and rely largely on expert opinion rather than objective risk stratification. In an analysis of 195 patients with no or small varices over an average follow-up of 5.3 years, the Disease Severity Index (DSI) from the HepQuant DuO test significantly predicted adverse clinical outcomes, demonstrating a stepwise increase in risk across stratified categories, while variceal size was not a significant predictor. These findings support incorporating DSI into surveillance strategies to better individualize the timing of repeat endoscopy and optimize care in cACLD. read more →
HepQuant DuO, HepQuant SHUNT
January 2026
Hepatic cholate clearance as assessed by HepQuant-SHUNT is associated with clinical outcomes in individuals with Fontan circulation
| International Journal of Cardiology Congenital Heart Disease
DOI: 10.1016/j.ijcchd.2026.100654 | PubMed ID: 41695267
Fontan-associated liver disease [FALD] is universal in individuals with Fontan circulation [FC]. The dual cholate clearance test is a noninvasive, flow-dependent measure of liver function. We aim to explore the association between cholate clearance and clinical outcomes in this population. read more →
HepQuant SHUNT
January 2026
Utilization of the Disease Severity Index (DSI) from the HepQuant DuO® Test Enhances Clinical Decision Making in Compensated Advanced Chronic Liver Disease.
| Journal of Clinical Medicine | January 2026
DOI: 10.3390/jcm15020501 | PubMed ID: 41598440
The HepQuant DuO® test is a noninvasive, blood-based test that assesses global liver health by quantifying liver function and physiology. The test generates a disease severity index (DSI) for assessment of risk for portal hypertension and large esophageal varices (LEV) to aid in the upper endoscopy (EGD) decision, provides a definition of disease severity to aid in clinical management, and enables serial testing to monitor changes in liver health over time, either improvement or worsening.
A DSI cutpoint 18.3 was defined in a U.S. multi-center trial in advanced chronic hepatitis C (HALT-C) and validated in a second U.S. multi-center trial where the majority of cases (52%) had MASLD/MASH (SHUNT-V). In addition, the latter validation study included all common etiologies of cACLD, and a high percentage of the study subjects were overweight, obese, elderly, and had diabetes. In several studies, DSI has shown favorable diagnostic performance compared to other noninvasive tests.
Using real-world data, the analysis evaluated the impact of DSI 18.3 in the EGD
decision and in modifying decision making in patients with cACLD. read more →
HepQuant DuO
November 2025
Cholate clearance: improving the assessment of liver health compared to current liver tests (LFTs)
| Gastro Hep Advances | November 2025
DOI: 10.1016/j.gastha.2025.100814 | PubMed ID: 41362815
Current liver function tests (LFTs) either indicate late-stage disease or hepatobiliary injury but do not accurately measure liver function. True quantitative liver function tests, analogous to creatinine clearance for the kidneys, are needed for assessing liver health.
read more →
HepQuant DuO
October 2025
Initial Clinical Experience With the Oral Cholate Challenge Test: Results From the 2023-2024 Early Access Program
| Liver International Communications | October 2025
DOI: 10.1002/lci2.70027
The oral cholate challenge test of liver health, intended for use in compensated advanced chronic liver disease, was launched through an Early Access Program (EAP) in 2023–2024. Tests were provided to 16 clinicians at five liver centres across the US. The tested patients (n = 129) represented a range of etiologies and stages of disease. Top clinical uses were: (1) informing the decision for endoscopy to test for varices (n = 56, 43%), (2) defining risk for large oesophageal varices (LEV) (n = 92, 71%), and (3)baseline for monitoring disease progression or treatment effects (n = 33, 26%). The test's disease severity index (DSI) stratified patients according to risk for portal hypertension and LEV: 49 (38%) low risk, 31 (24%) moderate risk and 49 (38%) high risk. The potential impact of DSI ≤ 18.3 on EGD avoidance (38%) in clinical practice replicated that which was observed in prior validation studies (41%). read more →
HepQuant DuO
August 2025
The Cholate Challenge Test Quantified Baseline Functional Heterogeneity and Improvement in Response to Resmetirom in MASH-related Child Pugh A Cirrhosis
| Gastro Hep Advances | August 2025
DOI: 10.1016/j.gastha.2025.100785 | PubMed ID: 41142528
In this study of MASH-related Child-Pugh A cirrhosis (MASH cirrhosis), we used the cholate challenge test to quantify baseline disease severity and the subsequent impact of resmetirom treatment. read more →
HepQuant DuO
April 2025
Assessment of the performance of a dual-sample oral cholate challenge test: The HepQuant DuO test
| Clinica Chimica Acta | April 2025
DOI: 10.1016/j.cca.2025.120325 | PubMed ID: 40262706
Liver health is currently evaluated using nonspecific blood tests, fibrosis surrogates, and invasive procedures, none of which directly measure liver function and physiology. The validated HepQuant SHUNT test quantifies liver function and physiology and is linked to clinical outcomes. Herein we present the reliability of a simplified version, the dual-sample oral cholate challenge (HepQuant DuO) test. read more →
HepQuant DuO
March 2025
Letter: Enhancing the Diagnostic Performance of the Oral Cholate Challenge Test – Implications for Avoidance of Potentially Unnecessary Endoscopy
| Alimentary Pharmacology & Therapeutics| March 2025
DOI: 10.1111/apt.70116 | PubMed ID: 40156280
HepQuant DuO, HepQuant SHUNT
March 2025
Alterations in Liver Perfusion in Adults with Fontan Circulation as Assessed by Dual Cholate Clearance
| Journal of the American Heart Association | 2025 | March 2025
DOI: 10.1161/JAHA.124.039479 | PubMed ID: 40118791
HepQuant SHUNT
March 2025
Rencofilstat Treatment Improves Liver Function in MASH With Advanced Fibrosis as Quantified by HepQuant DuO
| Liver International | 01 March 2025
DOI: 10.1111/liv.70036 | PubMed ID: 39982177
HepQuant DuO, HepQuant SHUNT
January 2025
Measuring the risk of clinical adverse events (RISK ACE) by quantifying liver function: A patient-centric model.
| European Journal of Internal Medicine 2024; 132:160-163 | 29 November 2024
DOI: 10.1016/j.ejim.2024.11.029 | PubMed ID: 39638649
HepQuant DuO, HepQuant SHUNT
January 2025
Cost-Effectiveness of an Oral Cholate Challenge Test for the Management of Patients at Risk for Large Esophageal Varices
| Research Article | published 22 November 2024 PLOS ONE
DOI: 10.1371/journal.pone.0313006 | PubMed ID: 39576797
HepQuant DuO, HepQuant SHUNT
January 2025
Cholate Shunt, Oral Cholate Challenge and Endoscopic Lesions of Portal Hypertension: The SHUNT-V Study.
| Alimentary Pharmacology & Therapeutics, 2024; 61: 75-87
DOI: 10.1111/apt.18386 | PubMed ID: 39523681
HepQuant DuO, HepQuant SHUNT
August 2024
A Validated LC-MS/MS Assay for the Quantification of Cholate Isotopes in Human Serum
| The Journal of Applied Laboratory Medicine 2024 Aug 16
DOI: 10.1093/jalm/jfae094 | PubMed ID: 39150903
HepQuant DuO
July 2024
The Oral Cholate Challenge Test Quantifies Risk for Liver-Related Clinical Outcomes in Primary Sclerosing Cholangitis
| Gastro Hep Advances 2024
DOI: 10.1016/j.gastha.2024.07.005 | PubMed ID: 39286620
HepQuant DuO
June 2024
Editorial: Reading the cholate—A new gateway to portal hypertension and oesophageal varices: Authors’ reply
| Aliment Pharmacol Ther 2024
DOI: 10.1111/apt.18128 | PubMed ID: 38924551
HepQuant DuO
June 2024
Hepatic improvement within 27 days of avenciguat treatment in Child-Pugh A cirrhosis detected by an oral cholate challenge test
| Liver Transplantation 2024 Jun 12
DOI: 10.1097/LVT.0000000000000420 | PubMed ID: 38869987
HepQuant SHUNT
May 2024
Liver Function and Portal-Systemic Shunting Quantified by the Oral Cholate Challenge Test and Risk for Large Esophageal Varices
| Aliment Pharmacol Ther 2024 May 22
DOI: 10.1111/apt.18054 | PubMed ID: 38778481
HepQuant DuO
April 2024
Hepatic Dysfunction Quantified by HepQuant DuO Outperforms Child-Pugh Classification in Predicting the Pharmacokinetics of Ampreloxetine
| Clin Pharmacol Ther 2024 Apr 23
DOI: 10.1002/cpt.3265 | PubMed ID: 38654484
HepQuant SHUNT
April 2024
Within-individual reproducibility of a dual sample oral cholate challenge test (DuO) and simplified versions of the HepQuant SHUNT test
| Clin Translational Sci 2024
DOI: 10.1111/cts.13786 | PubMed ID: 38558534
HepQuant DuO, HepQuant SHUNT
January 2024
Advances in Noninvasive Measurement of Liver Function and Physiology: The HepQuant DuO Test
| Basic Clin Pharmacol Toxicol 2024 Jan 15. Mar;134(3):385-395
DOI: 10.1111/bcpt.13980 | PubMed ID: 38225212
HepQuant DuO
December 2023
Dynamic elevation of aromatic amino acids in Hepatitis C Virus induced cirrhosis after a standard meal
| Clinical and Translational Gastroenterology 2024;15:e00666
DOI: 10.14309/ctg.0000000000000666 | PubMed ID: 38088382
HepQuant SHUNT
November 2023
Safety and pharmacokinetics of BI 685509, a soluble guanylyl cyclase activator, in patients with cirrhosis: A randomized Phase Ib study
| Hepatology Communications. 2023 Mar 0;7:e0276
DOI: 10.1097/HC9.0000000000000276 | PubMed ID: 37889522
HepQuant SHUNT
August 2022
Compartmental model describing the physiological basis for the HepQuant SHUNT test
| Transl Res. Volume 252, P53-63, February 2023
DOI: 10.1016/j.trsl.2022.08.002 | PubMed ID: 35948199
HepQuant DuO, HepQuant SHUNT
April 2021
HepQuant SHUNT Detects Portal Hypertension in Early Stages of Clinically Compensated Chronic Liver Disease
| Clin Gastroenterol Hepatol. 2021 Apr 22;S1542-3565(21)00464-X
DOI: 10.1016/j.cgh.2021.04.030 | PubMed ID: 33895359
HepQuant SHUNT
April 2021
How clinicians may use tests of hepatic function now and in the future
| Transl Res. 2021; 233:1-4
DOI: 10.1016/j.trsl.2021.03.014 | PubMed ID: 33826945
HepQuant SHUNT
March 2021
Authors’ Response to “Editorial: stratifying risk of adverse outcomes in cirrhosis: the Hepquant SHUNT test”
| Aliment Pharmacol Ther. 2021 Apr;53(8):941-942
DOI: 10.1111/apt.16311 | PubMed ID: 33745171
HepQuant SHUNT
March 2021
Editorial: stratifying risk of adverse outcomes in cirrhosis: the Hepquant SHUNT test
| Aliment Pharmacol Ther. 2021 Apr;53(8):939-940
DOI: 10.1111/apt.16299 | PubMed ID: 33745172
HepQuant SHUNT
February 2021
Predicting clinical decompensation in patients with cirrhosis using the HepQuant SHUNT Test
| Aliment Pharmacol Ther. 2021 Apr;53(8):928-938
DOI: 10.1111/apt.16283 | PubMed ID: 33556192
HepQuant SHUNT
January 2021
The within-individual reproducibility of the disease severity index from the HepQuant SHUNT test of liver function and physiology
| Transl Res. 2021 Jul;233:5-15
DOI: 10.1016/j.trsl.2020.12.010 | PubMed ID: 33400995
HepQuant SHUNT
August 2020
Deterioration in liver function after liver-directed therapy for hepatocellular carcinoma measured by cholate clearance
| GastroHep. 2020;2:232-239
DOI: 10.1002/ygh2.421
HepQuant SHUNT
August 2019
Assessing hepatic impairment in Fontan‐associated liver disease using the HepQuant SHUNT test
| Congenit Heart Dis. 2019; 14:978-986
DOI: 10.1111/chd.12831 | PubMed ID: 31369200
HepQuant SHUNT
February 2015
Noninvasive assessment of liver function
| Curr Opin Gastroenterol. 2015 May;31(3):199-208
DOI: 10.1097/MOG.0000000000000167 | PubMed ID: 25714706
HepQuant SHUNT
December 2012
Functional Elements Associated With Hepatic Regeneration in Living Donors After Right Hepatic Lobectomy
| Liver Transpl 2013; 19:292–304
DOI: 10.1002/lt.23592 | PubMed ID: 23239552
HepQuant SHUNT
March 2012
Quantitative Liver Function Tests Improve the Prediction of Clinical Outcomes in Chronic Hepatitis C: Results From the Hepatitis C Antiviral Long-term Treatment Against Cirrhosis Trial
| Hepatology 2012; 55:1019-1029
DOI: 10.1002/hep.24752 | PubMed ID: 22030902
HepQuant SHUNT
December 2008
Quantitative tests of liver function measure hepatic improvement after sustained virological response: Results from the HALT-C trial
| Aliment Pharmacol Ther., 29(5):589-601
DOI: 10.1111/j.1365-2036.2008.03908.x | PubMed ID: 19053983
HepQuant SHUNT
May 2008
The spectrum of hepatic functional impairment in compensated chronic hepatitis C: results from the Hepatitis C Anti-viral Long-term Treatment against Cirrhosis trial
| Aliment Pharmacol Ther. 27(9):798-809
DOI: 10.1111/j.1365-2036.2008.03639.x | PubMed ID: 18266997
HepQuant SHUNT
August 2007
Portal-systemic shunting in patients with fibrosis or cirrhosis due to chronic hepatitis C: the minimal model for measuring cholate clearances and shunt
| Aliment Pharmacol Ther, 26(3):401-10
DOI: 10.1111/j.1365-2036.2007.03389.x | PubMed ID: 17635375
HepQuant SHUNT